Campaign Launched Against Dietary Supplements by Bill Sardi

At a time when the Food and Drug Administration is under criticism for approving unsafe drugs, and when pharmaceutical companies are being called to task for not disclosing negative studies of their products, a concerted effort is being launched against dietary supplements. The obvious reason – don’t let the public discover dietary supplements as alternative to prescription drugs that can duplicate the biological action of most prescription medicines with far lower costs and side effects.

Harvard Medical School in a joint effort with the FDA and the Institute of Medicine, has released a report that says: "Unlike drugs, which must be proven safe before they can be sold, the current law allows sale of supplements unless the Food and Drug Administration can prove them harmful." The assumption is that prescription drugs are safer than supplements because they have undergone an FDA approval process. But a review of data from the US Poison Control Centers indicates vitamin and mineral supplements are linked with few if any deaths over the past few years and deaths linked to use of herbal products, except for ephedra, are few. For comparison, just the use of non-steroidal pain relievers like aspirin and ibuprofen cause an estimated 16,000 deaths annually. Side effects from properly used prescription drugs, administered by nurses in hospitals, result in over 100,000 deaths annually. The FDA approval process does not guarantee safety.

Public Citizen, the Ralph Nader group, indicates 181 FDA-approved drugs should be recalled because they are not as safe as other drugs or are ineffective. An FDA drug reviewer, Dr. David Graham, had to publish his report on the hidden dangers of Vioxx outside of the country in the British Medical Journal. His job was later threatened for not following FDA protocol even though an estimated 139,000 Americans died prematurely from the use of Vioxx.

Many drug side effects are the result of nutritional deficiencies caused by the medications themselves. But the FDA is stubbornly resistant to warn the public how to avoid drug side effects by taking companion supplements. For example, statin cholesterol-lowering drugs deplete the body of coenzyme Q10 which can result in a mortal condition called rhabdomyolysis. Acetaminophen (Tylenol) is toxic to the liver and acetaminophen use is the leading cause for liver transplants. The antidote for acetaminophen poisoning is N-acetyl cysteine, a sulfur-based dietary supplement. The FDA has resisted appeals to combine these nutrients into the drugs or mandate that supplements be prescribed as companions.

Another mistaken complaint is that dietary supplement manufacturers don’t have to report adverse reactions as do drug companies. Yet the FDA is obviously working in league with the drug companies to hide negative reports that could trigger the recall of many drugs.

Another false assumption in the report is that dietary supplements interfere with prescription medications. Hilary Tindle, MD, a research fellow at Harvard Medical School, and lead author of the report, says: "This is especially critical as more becomes known about the adverse effects associated with individual dietary supplements as well as their interactions with prescription drugs." But vitamins and minerals are essential for life and it is the drugs that interfere with the nutrients, not the other way around.

There is a concerted effort to regulate dietary supplements, which is in reality a smoke screen to limit dosages of vitamins and minerals that can replace many prescription drugs. For example, high-dose vitamin B6 and vitamin C reduce blood pressure equally as well as prescription medications. High-dose folic acid is a safe anti-depressant. High-dose vitamin D is as effective as many blood pressure pills. High-dose vitamin C can prevent a form of unstable plaque that causes most sudden-death heart attacks. Pharmaceutical companies are attempting to patent altered vitamin D molecules to treat cancer when high-dose vitamin D is inexpensive and has the same biological action.

Later in the year, CODEX, a trade organization linked with the World Health Organization, hopes to limit dosages of vitamins and minerals under the presumption high doses cause significant side effects. The Institute of Medicine report appears to be softening up the public for these limitations.

The report discloses the real reason for restrictions against dietary supplements – in their own words: "In the past five years the biggest change was an increase in use of herbal supplements." The pharmaceuticals companies see herbal remedies advancing while their problematic nostrums are being discredited.

The dietary supplement industry is continually characterized as some giant behemoth that must be curbed. The industry was responsible for $18.7 billion in sales in 2002. For comparison, the sales of just one class of drugs, statins for cholesterol, nearly equal the entire annual sales of dietary supplements.

Both the Harvard and Institutes of Medicine reports advised users of dietary supplements to disclose their supplement regimens to their doctors. But doctors are poorly educated in the use of vitamins, minerals and herbal products and would offer little help to consumers.

Harvard Medical School in a joint effort with the FDA and the Institute of Medicine, has released a report that says: "Unlike drugs, which must be proven safe before they can be sold, the current law allows sale of supplements unless the Food and Drug Administration can prove them harmful." The assumption is that prescription drugs are safer than supplements because they have undergone an FDA approval process. But a review of data from the US Poison Control Centers indicates vitamin and mineral supplements are linked with few if any deaths over the past few years and deaths linked to use of herbal products, except for ephedra, are few. For comparison, just the use of non-steroidal pain relievers like aspirin and ibuprofen cause an estimated 16,000 deaths annually. Side effects from properly used prescription drugs, administered by nurses in hospitals, result in over 100,000 deaths annually. The FDA approval process does not guarantee safety.

That point wasnt brought up at the congressional waist of tax dollars... whoops... hearing about steroids now was it?

Another point...

Since it is almost impossible to get a test scrip since it is a controlled substance now, and since test could be used to treat depression, do you guys think the new mandates are somehow involved in the pharmacutical companies rolling off depression medication after depression medication latley?

That point wasnt brought up at the congressional waist of tax dollars... whoops... hearing about steroids now was it?

No. However there is one legitimate point about deaths due to legal prescription drugs, and that is a higher number of deaths from one of two substances with the same exact level of toxicity and types of risks is to be expexted if more people are using one than the other. The fact that aspirin kills a few people a year has to be balanced in light of the pool of people using aspirin every year before it's used rhetorically like this. That's one of this article's weaker points.

Since it is almost impossible to get a test scrip since it is a controlled substance now, and since test could be used to treat depression, do you guys think the new mandates are somehow involved in the pharmacutical companies rolling off depression medication after depression medication latley?

I don't think anyone's thought of it that way. Most people still think testosterone is the Devil's seed and will turn an ordinary person into a raving lunatic.

Science and politics don't mix. I will raise some big time hell if I have to buy supplements through the black market because some Pharmaceutical companies want to push their drugs and have the rights to exclusively sell us supplements at an exaggerated cost. This is all a big money issue and the democrats or republicans won't help us, only we can help ourselves.

Science and politics don't mix. I will raise some big time hell if I have to buy supplements through the black market because some Pharmaceutical companies want to push their drugs and have the rights to exclusively sell us supplements at an exaggerated cost. This is all a big money issue and the democrats or republicans won't help us, only we can help ourselves.

It also helps illuminate a point I like to make that very few people never seem to take seriously, that legislation passed ostensibly to "protect" the public is really protectionist in nature and enforces monopolies for existing firms. All legislation can be analized this way, and for each piece of legislatio you often find a boatload of corporate benefactors and the public getting screwed.

...[S]ome Pharmaceutical companies want to push their drugs and have the rights to exclusively sell us supplements at an exaggerated cost. This is all a big money issue and the democrats or republicans won't help us, only we can help ourselves.

You've put your finger on it: big money.

Prior to WW2, the influence of "the money power" in public and in private affairs was a cause of alarm to members of all political parties, and had been so for more than 100 years.

In simple terms, business gets (by and large) what business wants, from government & in the marketplace; the bigger the business, the more of what it wants it gets.

In recent years, the barrier between corporate and regulatory spheres has been tissue-thin, & nowhere more transparently than @ the FDA, where the last several Directors have either come in from, or left for, a cushy/influential berth at a large pharmaceutical corp. While Big Pharma can't take control directly, they quite brazenly have their own people inside the agency, working to make things break the way the industry wants.

Remember the case of ephedra: probably more deaths are attributable to ephedrine (at least indirectly, as traffic & industrial accidents) than to ephedra, however, the OTC branch didn't like competing against their own raw material (much of Big Pharma depends on separating "active ingredients" from the "crude raw matter" they were discovered in), so it was just a matter of warping the public debate & biding their time. It also worked with steroids, and with prohormones, too. It'll keep on working as long as we act like it's an honest conversation that we somehow just can't win.

[quote=CDB]No. However there is one legitimate point about deaths due to legal prescription drugs, and that is a higher number of deaths from one of two substances with the same exact level of toxicity and types of risks is to be expexted if more people are using one than the other. The fact that aspirin kills a few people a year has to be balanced in light of the pool of people using aspirin every year before it's used rhetorically like this. That's one of this article's weaker points.

I would be against any law that limits my access to anything.However I have spent the last 25 years of my life experimenting with everything I could get my hands on in terms of supplements for physical,mental and lifestyle enhancement. Through much research and trial and error I have a good working knowledge of what works for me and I share that Info with anyone who asks.I think most of the people who frequent this board have similar experiences. Not,everyone is as dedicated to research as the membership of AM. Aspirin, Tylenol and cold medicines are over the counter meds they have little to no regulation. Uneducated people will take one pill and feel good, so they think if they take ten pills the will feel great. They have no concept of cycling or receptor down regulation.They just pop pills to feel better or because they heard it was good for them. This invariably leads to problems. The symptoms of these problems are physical,but the root cause is weakness of mind and character.This syndrome is not limited to the OTC world or pharm world.We all know people who abuse supplements and androgens. We all know how the hype machine works. The pharm companies use every legal way to sell their products. So do the natural supplement companies. They both bash each other with smear campaigns that are directed toward a fearful consumer. Senators just want to keep their cushy jobs. It only makes sense to support the stronger(i.e. more likely to vote)lobby, which is the pharm industry and their biggest end users the old and the sick. If a product works it can be bought and sold as a tradeable commodity. It is just the matter of who profits. It is my opinion that aspirin and vitamin C have helped alot more people than they have hurt. The real world is mean,unfair and sometimes people get hurt. It has never paid to be stupid. Most people find out the hard way.